Valerian receives UK boost with THMPD registration

Botanicals manufacturer Bio-Health is proving smaller companies can
cut it in the thrust and tumble of life under the Traditional
Herbal Medicinal Products Directive (THMPD), by having a valerian
product registered in the UK.

The proprietary valerian product, Valdrian, becomes the
15th​ product to be registered by the UK Medicines and
Healthcare products Regulatory Agency (MHRA), and is the first by a
wholly UK-based company.
Bio-Health marketing director June Crisp told NutraIngredients.com
her company's registration was proof that smaller companies were
not priced out of the THMPD registrations market.
Bio-Health spent about €60,000 on the registration that was lodged
with the MHRA on January31, 2007. Further registrations were being
sought in Greece and Ireland for Valdrian and the company was
preparing dossiers for two more of its herbal products that would
be submitted to the MHRA, probably early next year.
Registration benefits ​
"We are delighted to have received this registration and
excited by its potential,"​ she said. "We've always said
the THMPD can be beneficial to smaller companies because it
validates products and improves consumer confidence. We can now
legally make claims about the product, have greater export
opportunities and have no further worries about any potential
regulatory grey area." ​​Valdrian will be
permitted to state that it can be used "for temporary relief
from symptoms of mild anxiety".​
She urged other smaller botanicals players to move on registering
their products as the 2011 deadline was looming.
"After 2011, products that have not been registered won't be
allowed on-market. There will be internet back-door operators but
they will be clamped down on too. But we are a small company with
limited resources and we have proven these registrations are
economically viable as we have paid for it from our revenue streams
and have two more on the starting blocks." ​
Crisp said the Kent-based company aimed to have all its herbal
products registered by 2011
"The latest registration is the first granted to a small UK
manufacturer, Bio-Health Ltd, illustrating that the scheme can be
used by smaller as well as larger companies,"​ MHRA's head of
herbal policy, Richard Woodfield, told UK magazine, Natural
Products News​.
The previous MHRA registration was granted to another UK company,
Bioforce, for a St John's wort product called Hyperiforce.
MHRA has received applications from 10 companies, rejected none and
has about 20 applications in process.
In addition to the claims potential of a product registration, the
THMPD dictates that all herbal products not classified as food
supplements (like many 'spice rack' herbs such as garlic and sage)
or those considered medicines, must gain THMPD registration by
April 2011 to legally remain on market.
Germany and the UK have been the most active of the European
Union's 27 member states to date.
Bio-Health employs 20 staff and has annual revenue of about €1.2m.